Development of items to assess noticeability and sun sensitivity among patients with non-segmental vitiligo

OBJECTIVES: Non-segmental vitiligo (NSV) is a chronic skin disease characterized by progressive, bilateral skin depigmentation that can impact health-related quality of life and psychosocial well-being. To assess emerging and new NSV treatments, patient-reported outcomes (PROs) that capture patient-valued treatment outcomes and meaningful changes are needed. Two common aspects of NSV are vitiligo noticeability and sun sensitivity. Thus, PRO items assessing vitiligo noticeability and sun sensitivity were developed. This study aimed to evaluate the content validity and interpretability of the NSV noticeability and sun sensitivity PRO items. METHODS: In this cross-sectional, qualitative interview study, the NSV noticeability and sun sensitivity PRO items were tested in iterative hybrid concept confirmation and cognitive debriefing interviews with 24 adults (≥18 years) and 13 adolescents (12 to ≤17 years) with confirmed NSV. RESULTS: = 23), 73.9% noted this symptom was important. Following cognitive debriefing, item wording was simplified, and each item was split to separately assess facial vitiligo and body vitiligo. CONCLUSIONS: Combined, these findings underscore the importance of vitiligo noticeability and sun sensitivity among patients with NSV. The revised noticeability and sun sensitivity items, separately assessing the face and body, may provide a more comprehensive assessment of these outcomes experienced by people with NSV.